Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial

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ObjectiveTo test the primary hypothesis that a newer antihypertensive treatment regimen (calcium channel blocker ± an angiotensin converting enzyme inhibitor) is more effective than an older regimen (β-blocker ± a diuretic) in the primary prevention of coronary heart disease (CHD). To test a second primary hypothesis that a statin compared with placebo will further protect against CHD endpoints in hypertensive subjects with a total cholesterol 6.5 mmol/l.DesignProspective, randomized, open, blinded endpoint trial with a double-blinded 2 × 2 factorial component.SettingPatients were recruited mainly from general practices.PatientsMen and women aged 40–79 were eligible if their blood pressure was ≥160 mmHg systolic or ≥ 100 mmHg diastolic (untreated) or ≥140 mmHg systolic or ≥ 90 mmHg diastolic (treated) at randomization.InterventionsPatients received either amlodipine (5/10 mg) ± perindopril (4/8 mg) or atenolol (50/100 mg) ± bendroflumethiazide (1.25/2.5 mg) +K+ with further therapy as required to reach a blood pressure of ≤140 mmHg systolic and 90 mmHg diastolic. Patients with a total cholesterol of ≤ 6.5 mmol/l were further randomized to receive either atorvastatin 10 mg or placebo daily.Main outcome measureNon-fatal myocardial infarction (MI) and fatal coronary heart disease (CHD).Results19 342 men and women were initially randomized, of these 10 297 were also randomized into the lipid-lowering limb. All patients had three or more additional cardiovascular risk factors.ConclusionsThe study has 80% power (at the 5% level) to detect a relative difference of 20% in CHD endpoints between the calcium channel blocker-based regimen and the β-blocker-based regimen. The lipid-lowering limb of the study has 90% power at the 1% level to detect a relative difference of 30% in CHD endpoints between groups.

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